MAUDE Adverse Event Report: ACCLARENT, INC. RELIEVA FLEX SINUS GUIDE CATHETER, F-70C; CANNULA, SINUS

Catalog Number	GC070CRF
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).[conclusion]: acclarent was informed on 10/30/2018, of an event that occurred on (b)(6) 2018, involving the relieva flex sinus guide catheter f-70c (gc070crf / 180405a-pc).During the hybrid functional endoscopic sinus surgery (fess) procedure, the blue tip on the relieva flex sinus guide catheter broke off the guide catheter.It was reported that nothing was left inside the patient¿s anatomy; there was no harm or adverse event to the patient.Another guide catheter was opened as a replacement and the procedure was completed.The relieva flex sinus guide catheter f-70c and the separated blue tip were returned for evaluation.The investigation finding is documented below.The lot history record (lhr) was reviewed for lot 180405a-pc.No anomalies were found related to this complaint.In addition, the lhr review verifies that the device was manufactured in accordance with documented specification and procedures.Acclarent received the returned device on 11/19/2018.The package included the following: the relieva flex sinus guide catheter f-70c.The separated blue tip of the guide catheter.Upon receiving the returned device before decontamination, the returned device underwent visual inspected.The relieva flex sinus guide catheter was noted to have a missing blue tip.The separated blue tip included in the package was covered in dry blood.The device underwent decontamination for two hours in a 10% bleach solution.After decontamination, the guide catheter was inspected under the microscope and the reported issue that the blue tip became separated from the guide catheter as reported in the complaint was confirmed.With the information provided in the complaint and the returned device for investigation, the issue reported that the blue tip broke off the guide catheter was confirmed from visual inspection and microscopic inspection of the returned device.Based on the lot history record (lhr) review, there is no indication that the event is related to the device manufacturing process.The exact cause of the failure could not be conclusively determined; however, it is possible that circumstances of the procedure and/or device manipulation/interaction may have contributed to the reported failure.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
Acclarent was informed on 10/30/2018, of an event that occurred on (b)(6) 2018, involving the relieva flex sinus guide catheter f-70c (gc070crf / 180405a-pc).During the hybrid functional endoscopic sinus surgery (fess) procedure, the blue tip on the relieva flex sinus guide catheter broke off the guide catheter.It was reported that nothing was left inside the patient¿s anatomy; there was no harm or adverse event to the patient.Another guide catheter was opened as a replacement and the procedure was completed.The guide catheter and the separated blue tip will be returned for evaluation.

• Brand Name: RELIEVA FLEX SINUS GUIDE CATHETER, F-70C
• Common Device Name: CANNULA, SINUS
• Manufacturer (Section D): ACCLARENT, INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 8096703
• Report Number: 3005172759-2018-00115
• Device Sequence Number: 2015647
• Product Code: LRC
• UDI-Device Identifier: 10705031063426
• UDI-Public: 10705031063426
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K043445
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/05/2020
• Device Catalogue Number: GC070CRF
• Device Lot Number: 180405A-PC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/31/2018
• Initial Report FDA Received Date: 11/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1